Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
1 other identifier
interventional
8,374
1 country
40
Brief Summary
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 healthy
Started Apr 2014
Typical duration for phase_3 healthy
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 10, 2018
CompletedMarch 20, 2019
March 1, 2019
1.5 years
April 15, 2014
December 8, 2017
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Week 56
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
Week 28
Study Arms (2)
HEPLISAV
EXPERIMENTAL0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
Engerix-B
ACTIVE COMPARATOR1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.
Interventions
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Intramuscular injections at Week 0, Week 4, and Week 24
Eligibility Criteria
You may qualify if:
- Be 18-70 years of age, inclusive
- Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
- If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
- Able and willing to provide informed consent
- A subject with any one of the following criteria is not eligible for the trial:
You may not qualify if:
- Previous receipt of any hepatitis B vaccine
- History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
- History of autoimmune disorder
- History of sensitivity to any component of study vaccines
- Has received the following prior to the first injection:
- Within 28 days:
- Any vaccine
- Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
- Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Any other investigational medicinal agent
- Within 90 days: Blood products or immunoglobulin
- At any time: An injection of DNA plasmids or oligonucleotide
- If female: Pregnant, nursing, or planning to become pregnant during the trial
- Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
- Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Clinical Research Advantage, Inc.
Birmingham, Alabama, 35211, United States
Clinical Research Advantage, Inc.
Chandler, Arizona, 85224, United States
Radiant Research
Chandler, Arizona, 85224, United States
Clinical Research Advantage, Inc.
Glendale, Arizona, 85306, United States
Clinical Research Advantage, Inc.
Mesa, Arizona, 85206, United States
Clinical Research Advantage, Inc.
Mesa, Arizona, 85213, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85018, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85020, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85050, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, 85283, United States
Radiant Research
Tucson, Arizona, 85712, United States
Clinical Research Advantage, Inc.
Tucson, Arizona, 85741, United States
Radiant Research
Santa Rosa, California, 95405, United States
Clinical Research Advantage, Inc.
Vista, California, 92083, United States
Clinical Research Advantage, Inc.
Centennial, Colorado, 80112, United States
Clinical Research Advantage, Inc.
Colorado Springs, Colorado, 80922, United States
Radiant Research
Denver, Colorado, 80239, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Radiant Research
Atlanta, Georgia, 30342, United States
Radiant Research
Chicago, Illinois, 60654, United States
Clinical Research Advantage, Inc
Evansville, Indiana, 47725, United States
Clinical Research Advantage, Inc.
Council Bluffs, Iowa, 51503, United States
Radiant Research
Edina, Minnesota, 55435, United States
Radiant Research
St Louis, Missouri, 83141, United States
Clinical Research Advantage, Inc.
Elkhorn, Nebraska, 68022, United States
Clinical Research Advantage, Inc.
Fremont, Nebraska, 68025, United States
Clinical Research Advantage, Inc.
Omaha, Nebraska, 68124, United States
Clinical Research Advantage, Inc.
Henderson, Nevada, 89052, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128, United States
Radiant Research
Akron, Ohio, 44311, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Radiant Research
Columbus, Ohio, 43212, United States
Clinical Research Advantage, Inc.
Anderson, South Carolina, 29621, United States
Radiant Research
Anderson, South Carolina, 29621, United States
Radiant Research
Greer, South Carolina, 29650, United States
Radiant Research
Dallas, Texas, 75231, United States
Clinical Research Advantage, Inc.
Plano, Texas, 75093, United States
Radiant Research
San Antonio, Texas, 78229, United States
Radiant Research
Murray, Utah, 84123, United States
Related Publications (2)
Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
PMID: 31431412DERIVEDJackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
PMID: 29289383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Janssen MD \ VP & Chief Medical Officer
- Organization
- Dynavax Technologies, Inc.
Study Officials
- STUDY DIRECTOR
Robert Janssen, MD
Dynavax Technologies Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 20, 2019
Results First Posted
January 10, 2018
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share